Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

February 21, 2019 updated by: Nobelpharma

A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults

The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Matsudo, Chiba, Japan, 270 -2231
        • Clinique Soigner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Japanese healthy subjects aged 20 to 39 years of age
  2. Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
  3. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
  4. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
  5. Subjects who write informed consent
  6. Subjects who are able to comply with the study requirements during the study period

Exclusion Criteria:

  1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
  2. Subjects who have a history of hypersensitivity or allergies to other drug
  3. SUbjects who have an acute or chronic infectious diseases
  4. Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
  5. Subjects who have diagnosed with alcoholism or a history of alcoholism
  6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
  7. Subjects who have been administered other investigational drug within 12 weeks before the initial administration

  8. Subjects who have performed blood collection or donation as follows

    • Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
    • Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
    • Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
    • Collected or donated blood component within 2 weeks before the initial administration
  9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
  10. Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
  11. Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
  12. Subjects who cannot speak, read and write in Japanese
  13. Subjects who are considered by the investigator as unsuitable for participation in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: NPC-12 granule
NPC-12 granules (1.0g: 2mg sirolimus)
Drug: sirolimus
SIngle administration under fasted condition
Active Comparator: NPC-12T tablet
NPC-12T 2 tablets (2mg sirolimus)
Drug: sirolimus
SIngle administration under fasted condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood sirolimus concentration
Time Frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)
Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.
Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nobelpharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPC-12T-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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